The Evolving Paradigm for Clinical Development and Regulatory Approval of Antiretroviral Drugs in the United States
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Information Jounual. Vol. 33. pp. 357-372, 1999 Printed in the USA. All rights reserved.
Drug
Copyright 0 1999 Drug Information Association Inc.
THE EVOLVING PARADIGM FOR CLINICAL DEVELOPMENT AND REGULATORY APPROVAL OF ANTIRETROVIRAL DRUGS IN THE UNITED STATES DAVIDM. COCCHE-ITO, PHD, AND LYNNSMILEY,MD Departments of Regulatory Affairs and Antiviral Clinical Research, Glaxo Wellcome Inc., Research Triangle Park, North Carolina
The pharmaceutical industry and the Food and Drug Administration (FDA) have responded for over a decade to the considerable challenges of drug development and registration, as introduced b y the HIV epidemic. FDA took a variew of regulatory steps over a period of 7 to 10 years which facilitated various aspects of the process of developing antiretroviral drugs. This manuscript will discuss the various major evolutionary milestones in the paradigm for development and approval of antiretroviral drugs in the United States. Maintenance of this effort over the last decade demonstrates the dedication of FDA and industry to this field, The initiatives of FDA and the pharmaceutical industry have facilitated drug development and early access to important multiple, new antiretroviral drugs. The sections provide detailed information to support these views and suggest that consideration be given to applying these lessons to the broader challenge of expediting development of other classes of drugs. Key Words: Antiretrovial drugs; United States; Food and Drug Administration; Drug development
INTRODUCTION CLINICAL DEVELOPMENT OF new drugs for the treatment of HIV infection and AIDS has evolved extensively over the last decade. This evolution has been necessary and appropriate in response to several factors, including:
1. Changes over time in the antiretroviral armamentarium, 2. Demonstration of greater clinical benefits from various combination therapies compared with certain monotherapies, 3. Growing experience with, and knowledge of, surrogate endpoints (particularly CD4 cell count and plasma HIV RNA), 4. Expanding knowledge of viral replication and its role in HIV disease, and 5. The importance of achieving substantial antiretroviral effects and sustaining these effects over time.
Presented at the DIA 34th Annual Meeting "Thinking Globally: Product Development, Registration, and Marketing in the New Millennium," June 7-11, 1998, Boston. Massachusetts. An historical perspective on the approved Reprint address: David M. Cocchetto, PhD, Glaxo antiretroviral Research ~ ip d , ~ ~ l agents ~ will illustrate some key Wellcome lnc., 5 M~~~ +,e-, aspects of this evolutionary process. This hisNC 21109.
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David M. Cocchetto and Lynn Smiley
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torical perspective also serves as the foundation for the next steps in the process.
AN HISTORICAL PERSPECTIVE Retrovir@(zidovudine; ZDV) capsules was the first antiretroviral drug to receive FDA approval. This approval was issued in March 1987. Approval of Retrovir was based primarily on a double-blind,
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